BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9667812 · Received February 4, 2020

    Report

    Report Number
    1710034-2020-00053
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 14, 2020
    Report Date
    March 2, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DHR FOR LOT NUMBER 9241111 HAS BEEN REVIEWED, ONE RELATED QUALITY NOTIFICATION WAS FOUND QN #(B)(4). THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING HAD A HOLE IN IT THAT WAS NOTICED DURING USE WHEN IT BEGAN LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SALINE LINE TUBING WAS NOTED TO HAVE A HOLE AFTER INSERTION THE SITE WAS LEAKING HAD TO BE REMOVED AND NEW LINE INSERTED INTO PATIENT. INCIDENT SAMPLE DISPOSED, BUT RN COULD CLEARLY SEE HOLE IN EXTENSION TUBING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING HAD A HOLE IN IT THAT WAS NOTICED DURING USE WHEN IT BEGAN LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SALINE LINE TUBING WAS NOTED TO HAVE A HOLE AFTER INSERTION THE SITE WAS LEAKING HAD TO BE REMOVED AND NEW LINE INSERTED INTO PATIENT. INCIDENT SAMPLE DISPOSED, BUT RN COULD CLEARLY SEE HOLE IN EXTENSION TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132146 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9241111 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other